Dose-response Study of Exendin-9,39 on Glucose Metabolism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adrian Vella, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01218633
First received: October 8, 2010
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

Multiple studies have examined the effect of endogenous GLP-1 secretions by using a competitive antagonist of GLP-1 - Exendin-9,39 - infused at rates of 300pmol/kg/min. However, the presence of an effect does not necessarily imply that this effect is due to the blockade of the endogenous GLP-1 actions at the receptor. It is possible that the supraphysiologic concentrations of Exendin may have effects of its own. To examine the effect of Exendin on glucose metabolism the investigators propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion.


Condition Intervention Phase
Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1
Drug: saline infusion
Drug: GLP-1-9,36 infusion
Drug: Exendin-9,39 at low dose
Drug: Exendin-9,39 at high dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Dose-response Study of the Effects of Exendin-9,39 on Glucose Metabolism, Glucagon and Insulin Secretion and on Insulin Action.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Insulin Secretion [ Time Frame: over 360 minutes of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • glucagon secretion [ Time Frame: over 360 minutes of study ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline Drug: saline infusion
saline infused at 30ml/hour
Active Comparator: GLP-1-(9,36)-amide Drug: GLP-1-9,36 infusion
infused @ 1.2pmol/kg/min
Active Comparator: Exendin-9,39 @30pmol/kg/min Drug: Exendin-9,39 at low dose
infused at 30pmol/kg/min
Active Comparator: Exendin-9,39 @300pmol/kg/min Drug: Exendin-9,39 at high dose
infused @ 300pmol/kg/min

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Healthy Not on any medication other than thyroid hormone replacement or OCP No history of diabetes No prior upper GI surgery

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01218633

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Adrian Vella
Investigators
Principal Investigator: Adrian Vella, MD Mayo Clinic
  More Information

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adrian Vella, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01218633     History of Changes
Other Study ID Numbers: 10-003435
Study First Received: October 8, 2010
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 27, 2014